PMID- 37559872 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230811 IS - 2352-3204 (Electronic) IS - 2352-3204 (Linking) VI - 24 DP - 2023 Dec TI - Characterization of dynamical changes in vital signs during allogeneic human umbilical cord-derived mesenchymal stem cells infusion. PG - 282-287 LID - 10.1016/j.reth.2023.07.007 [doi] AB - Human umbilical cord-derived mesenchymal stem cells (hUC-MSCs), a kind of adult stem cell, were studied for clinical applications in regenerative medicine. To date, the safety evaluations of intravenous infusion of allogeneic hUC-MSCs were focused on fever, infection, malignancy, and death. However, the characteristics of dynamical changes in vital signs during hUC-MSCs infusion are largely unknown. In this study, twenty participants with allogeneic hUC-MSCs transplanted (MSC group) and twenty sex- and age-matched individuals with cardiovascular disease who treated with the equal volume of 0.9% normal saline were recruited (NS group). Heart rate, respiratory rate, oxygen saturation, systolic and diastolic blood pressure, and temperature were monitored at intervals of 15 min during infusion. Adverse events were recorded during infusion and within seven days after infusion. No adverse events were observed during and after infusion in both groups. Compared with the baseline, the mean systolic blood pressure (SBP) levels were significantly decreased at 15 min, 30 min, 45 min and 60 min in the MSC group (all P < 0.05) during infusion. In addition, SBP changed significantly from baseline during hUC-MSCs infusion when compared with that of NS group (P < 0.05). Repeated measures analysis of variance confirmed difference over time on the SBP levels (P < 0.05). Our results showed that the process of allogeneic hUC-MSCs intravenous infusion was safe and the vital signs were stable, whereas a slight decrease in SBP was observed. CI - (c) 2023 The Japanese Society for Regenerative Medicine. Production and hosting by Elsevier B.V. FAU - Wang, Yue AU - Wang Y AD - Clinical Research Center for Cell Therapy, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai 200120, China. FAU - Yu, Haiping AU - Yu H AD - Nursing Department, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai 200120, China. FAU - Tang, Hongming AU - Tang H AD - Clinical Research Center for Cell Therapy, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai 200120, China. AD - Translational Medical Center for Stem Cell Therapy, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai 200120, China. FAU - Zhu, Rong AU - Zhu R AD - Clinical Research Center for Cell Therapy, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai 200120, China. FAU - Shi, Yiqi AU - Shi Y AD - Clinical Research Center for Cell Therapy, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai 200120, China. FAU - Xu, Changqin AU - Xu C AD - Clinical Research Center for Cell Therapy, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai 200120, China. FAU - Li, Yan AU - Li Y AD - Clinical Research Center for Cell Therapy, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai 200120, China. FAU - Wang, Hua AU - Wang H AD - Catheterization Room, Seventh People's Hospital of Shanghai University of Traditional Chinese Medicine, Shanghai 200137, China. FAU - Chen, Yuanyuan AU - Chen Y AD - Translational Medical Center for Stem Cell Therapy, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai 200120, China. FAU - Shen, Peichen AU - Shen P AD - Department of Medicine, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai 200120, China. FAU - Xu, Jinfang AU - Xu J AD - Department of Health Statistics, Second Military Medical University, Shanghai 200433, China. FAU - Wang, Congrong AU - Wang C AD - Department of Endocrinology & Metabolism, Shanghai Fourth People's Hospital, School of Medicine, Tongji University, Shanghai 200434, China. FAU - Liu, Zhongmin AU - Liu Z AD - Clinical Research Center for Cell Therapy, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai 200120, China. AD - Translational Medical Center for Stem Cell Therapy, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai 200120, China. LA - eng PT - Journal Article DEP - 20230802 PL - Netherlands TA - Regen Ther JT - Regenerative therapy JID - 101709085 PMC - PMC10407816 OTO - NOTNLM OT - Allogeneic OT - Human umbilical cord OT - Infusion OT - Mesenchymal stem cells OT - Vital signs COIS- The authors declare that they have no competing interests. EDAT- 2023/08/10 06:43 MHDA- 2023/08/10 06:44 PMCR- 2023/08/02 CRDT- 2023/08/10 04:05 PHST- 2023/03/31 00:00 [received] PHST- 2023/06/15 00:00 [revised] PHST- 2023/07/26 00:00 [accepted] PHST- 2023/08/10 06:44 [medline] PHST- 2023/08/10 06:43 [pubmed] PHST- 2023/08/10 04:05 [entrez] PHST- 2023/08/02 00:00 [pmc-release] AID - S2352-3204(23)00073-1 [pii] AID - 10.1016/j.reth.2023.07.007 [doi] PST - epublish SO - Regen Ther. 2023 Aug 2;24:282-287. doi: 10.1016/j.reth.2023.07.007. eCollection 2023 Dec.